MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET ADT; OXIMETER

Model Number	4000
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
Event or Problem Description
The customer reported at 0940 on (b)(6) 2018 rn called masimo cs on site to room 10f bed 12 as pox was not picking up.Rd adt on l middle finger with top adhesive flaps wrapped around the finger first and then the bottom adhesive flaps over the top.Attempted new adt on r ring finger and would pick up intermittently and then drop out with flat line.Changed cable and attached to new sensor and obtained signal.Pulled old cable and sensor.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.

• Brand Name: RD SET ADT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7239762
• Report Number: 2031172-2018-00055
• Device Sequence Number: 1274582
• Product Code: DQA
• UDI-Device Identifier: 10843997009567
• UDI-Public: 10843997009567
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2020
• Device Model Number: 4000
• Device Catalogue Number: 4000
• Device Lot Number: 17NBG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 02/03/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1